Continuous treatment with a 2% topical testosterone solution may help to improve low sex drive and low-energy symptoms in men with hypogonadism, study data show.
“Controversy remains a major issue with testosterone therapy, and as a consequence of the hype in the media related to safety, many affected men do not seek physician advice,” Gerald Brock, MD, professor of surgery, division of urology, Western University in London, Ontario, Canada, told Endocrine Today. “This study, like many others, demonstrates safety and efficacy in those testosterone-deficient individuals. We need larger and longer duration studies in these men to reassure the public and the media of the value of treatment.”
Brock and colleagues conducted an extension study of a 3-month, double blind, placebo- controlled study (June 2013-October 2014) in which 558 men with hypogonadism entered a 6-month open-label study to determine the safety and efficacy of continued testosterone solution 2% treatment. The open-label phase of the study was completed in April 2015. During the first part of the study, 275 participants received placebo and 283 received treatment with testosterone solution. All participants enrolled in the current study began a daily dose of 60 mg testosterone solution.
Participants completed the Sexual Arousal, Interest and Drive scale and the Hypogonadism Energy Diary to report treatment efficacy.
Testosterone levels were in the normal range for 60% of participants who were in the placebo group during the previous study and 66% of those who were in the treatment group. The Sexual Arousal, Interest and Drive scale scores also increased from the beginning of the open-label study to 36 weeks (P < .001 for both formerly placebo group and formerly active group). Similarly, scores on the Hypogonadism Energy Diary were improved for both groups (P < .001 for both).
“The study found that patients who received [testosterone solution] during the open-label phase had improved symptoms regardless of whether they had received placebo during the blinded phase,” Brock told Endocrine Today. “Those who had received [testosterone solution] in the blinded phase also continued to improve, suggesting that [testosterone solution] treatment efficacy does not plateau in the first few months. Treatment with [testosterone solution] for up to 9 months was generally well tolerated, and 6 months of extended treatment not only maintained the improvement of low sex drive and low energy seen in the double blind phase, but also continued to improve these symptoms.” – by Amber Cox
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Gerald Brock, MD, can be reached at 519-646-6042.
Disclosure: Brock reports various financial ties with Abbott, Astellas Pharma, Eli Lilly and Company, Ferring, Johnson & Johnson and Pfizer.